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| Primary information |
|---|
| ID | 11586 |
| Therapeutic ID | Th1251 |
| Protein Name | Albumin human |
| Sequence | >Th1251_Albumin_human
MKWVTFISLLFLFSSAYSRGVFRRDAHKSEVAHRFKDLGEENFKALVLIAFAQYLQQCPFEDHVKLVNEVTEFAKTCVADESAENCDKSLHTLFGDKLCTVATLRETYGEMADCCAKQEPERNECFLQHKDDNPNLPRLVRPEVDVMCTAFHDNEETFLKKYLYEIARRHPYFYAPELLFFAKRYKAAFTECCQAADKAACLLPKLDELRDEGKASSAKQRLKCASLQKFGERAFKAWAVARLSQRFPKAEFAEVSKLVTDLTKVHTECCHGDLLECADDRADLAKYICENQDSISSKLKECCEKPLLEKSHCIAEVENDEMPADLPSLAADFVESKDVCKNYAEAKDVFLGMFLYEYARRHPDYSVVLLLRLAKTYETTLEKCCAAADPHECYAKVFDEFKPLVEEPQNLIKQNCELFEQLGEYKFQNALLVRYTKKVPQVSTPTLVEVSRNLGKVGSKCCKHPEAKRMPCAEDYLSVVLNQLCVLHEKTPVSDRVTKCCTESLVNRRPCFSALEVDETYVPKEFNAETFTFHADICTLSEKERQIKKQTALVELVKHKPKATKEQLKAVMDDFAAFVEKCCKADDKETCFAEEGKKLVAASQAALGL
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| Molecular Weight | 66472.2 |
| Chemical Formula | C2936H4624N786O889S41 |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | NA |
| Description | Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood [A33706]. It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans [A40060]. Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) [A40060]. There are various preparations of albumin that are well established and widely available in the clinical setting [L3108], [L3109], [L3101]. Also known as _Albuminex_ 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US [F229]. This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 [L3101]. |
| Indication/Disease | Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass [F229]. |
| Pharmacodynamics | Serum albumin is a soluble, monomeric protein essential for maintaining and regulating the colloidal osmotic pressure of blood. It is utilized to increase the circulating plasma volume, which reduces hemoconcentration and blood viscosity. Albumin is also used as a transport protein that binds naturally occurring, therapeutic and toxic materials and drugs in the circulation [F229]. Human albumin makes up over 50% the total protein in the plasma and represents about 10% of protein synthesis activity by the liver. Human Albumin 25% has a corresponding hyper-oncotic effect [F230]. |
| Mechanism of Action | The main function of albumin results from its contribution to plasma colloid oncotic pressure and transport function [F230]. Albumin stabilizes circulating blood volume and carries hormones, enzymes, medicines, and toxins. Other physiological functions include antioxidant properties, free radical scavenging, in addition to maintenance capillary membrane integrity [F230]. Exogenously administered albumin increases the oncotic pressure of the intravascular system, moving fluids from the interstitial space, thereby decreasing edema and increasing the circulating blood volume. The increase in volume reduces the concentration and viscosity of blood in patients with decreased circulating blood volume while maintaining cardiac output in shock. In dehydrated patients, negligible effects exist on circulating blood volume. In addition to the above albumin replaces protein in patients with hypoproteinemia until the cause of the deficiency can be determined [L3104]. This drug has thousands of endogenous and exogenous targets. Human albumin also binds and carries a plethora of hydrophobic molecules, such as endogenous (i.e., cholesterol, fatty acids, bilirubin, thyroxine) or exogenous substances (for example, drugs and toxins), transition metal ions, as well as gas (nitric oxide [NO]), with resulting implications for their solubilisation, transport, metabolism, and detoxification [A40060]. |
| Toxicity | In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated [F229]. The most common adverse reactions are rigors, hypotension, tachycardia with increased heart rate, fever, chills, nausea, vomiting, dyspnea and/or bronchospasm, skin rash/pruritus. Stop the infusion immediately if anaphylaxis, with or without shock is observed [F229]. Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the volume status of the patient. When clinical signs of cardiovascular overload occur (headache, dyspnea, jugular venous distention, increased blood pressure), the infusion must be slowed or stopped immediately [F230]. |
| Metabolism | NA |
| Absorption | NA |
| Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid space [F230]. In healthy adults, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion of albumin. There is considerable individual variation in the effect of albumin on plasma volume, however [F229], [F230]. In some patients, the plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate that is difficult to predict [F230]. |
| Clearance | NA |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Nitric oxide |
| Brand Name | Albuminex |
| Company | BPL |
| Brand Description | BPL |
| Prescribed For | Intravenous |
| Chemical Name | 0.05 g/1mL |
| Formulation | ALBUMINEX 5% is contraindicated in patients with: Hypersensitivity to human albumin or any of the excipients Severe anemia or cardiac failure with normal or increased intravascular volume |
| Physical Appearance | chills (may be severe), low blood pressure (hypotension), increased heart rate, fever, nausea, vomiting, shortness of breath/bronchospasm, rash, and itching |
| Route of Administration | ALBUMINEX 5% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative. |
| Recommended Dosage | ALBUMINEX 5% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In pediatric patients to reverse hypovolemia and achieve normal capillary refill time.1,2,3,4,5,6,7,8 |
| Contraindication | NA |
| Side Effects | The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |